Periodic Reporting for period 1 - SERENITY (Towards Cancer Patient Empowerment for Optimal Use of Antithrombotic Therapy at the End of Life)
Periodo di rendicontazione: 2022-10-01 al 2024-03-31
Despite the fact that antithrombotic therapy (ATT) has little or even negative effects on the well-being of cancer patients during their last year of life, stopping ATT is rare in clinical practice. In contrast, ATT is often continued until death, resulting in excess bleeding, higher healthcare costs, and increased disease burden. SERENITY will develop an information-driven, palliative care shared decision-making process enabled by a userfriendly, easily accessible, web-based shared decision support tool (SDST) that will facilitate treatment decisions regarding appropriate use of ATT in cancer patients at the end of life. SERENITY will use a comprehensive approach consisting of a combination of realist review, flash mob research, three epidemiologic studies in NL, UK, and DK, and qualitative interviews. The results of these studies will be used in a Delphi process to reach consensus on the optimal design of the intervention. Using the consensus reached in the Delphi process, the SDST will be designed to be patient-specific with adaption to gender, cancer-related, cultural, and socioeconomic factors. Proceeding, the SDST will be tested and optimised in a Randomised Clinical Trial. A targeted implementation and exploitation plan will be developed to enable the use of the SERENITY approach across Europe, as well as incorporation in national and pan-European clinical guidelines and policies. The intervention will ultimately lead to appropriate use of ATT, prevention of bleeding
complications, and considerable cost savings in addition to improved quality of life and treatment satisfaction of patients, their carers, and involved healthcare professionals. The intervention will empower cancer patients and their carers, enabling them to make their own choices. The intervention will reduce the disease burden of hundreds of thousands of people living with cancer receiving palliative care each year, throughout all EU regions.
complications, and considerable cost savings in addition to improved quality of life and treatment satisfaction of patients, their carers, and involved healthcare professionals. The intervention will empower cancer patients and their carers, enabling them to make their own choices. The intervention will reduce the disease burden of hundreds of thousands of people living with cancer receiving palliative care each year, throughout all EU regions.
Realist Review:
A theory-driven approach that aims to uncover the explanatory mechanisms that underpin interventions and how context affects the success or failure of intended outcomes.
The review protocol was developed and accepted on the PROSPERO Registry (CRD42022375000, 14 November 2022).
Four online stakeholder meetings were held across the 12 months of the review to ensure relevancy of the review questions and to identify any gaps as the data analysis progressed.
We summarised our findings under three themes:
1. The ‘prescribing inertia’ problem in end-of-life care
2. Shared decision-making in end-of-life deprescribing
3. Education, training and decision support for end-of-life shared decision-making
Manuscript is completed.
Flash mob research:
(UMCM) – 1 October 2022 to 1 October 2024
Study protocol version 1.0 of 23 January 2023 describing the procedures and timelines of this survey according to the flash mob approach was jointly prepared by UMCM and LUMC.
Data analysis and evaluation was jointly performed by UMCM and LUMC.
Manuscript is completed.
Epidemiological studies:
Contributing centers
Aalborg University Hospital: Danish Center for Health Services Research
Erasmus Medical Center: Department of Hematology
Leiden University Medical Center: Department of Internal Medicine, section Thrombosis and Hemostasis & Department of Clinical Epidemiology
Cardiff University: Division of Population Medicine
University Medical Center Utrecht: Julius Center for Health Sciences and Primary Care
Data analysis was standardized across the different settings and countries (definitions, CODE selection), and data has been analyzed and shared during several consortium meeting. Several manuscripts are anticipated this year, one manuscript is completed.
Qualitative studies:
The team in Denmark and Wales drafted the qualitative protocol, and supporting documents, including the participant information sheets (for patients, companions and clinicians), consent forms, and interview schedule/guide.
Interviews were conducted between April 2023 – March 2024. A total of 60 patients (13 companions) and 77 clinicians have been interviewed over this period (see Table 1 and 2). The minimum target recruitment has been reached (minimum 60 patients and 72 clinicians across all countries).
Data analysis
The data are being analysed using Framework Analysis; to date, analysis is well underway
Consensus/Delphi analysis
During the reporting period, the WP4 coordination group has been preparing the consensus process. To complete the documents and prepare the different meetings committee, members of the WP4 coordination group have been holding regular meetings. To establish the final framework of the Delphi, several steps were necessary, each playing a crucial role in the process: creation of a Steering Committee, consideration of aspects of the protocol, particularly defining the composition of the Delphi panel, and developing the Delphi content.
Design and development of the SDST
A comprehensive journey for both patients and clinicians was designed, emphasizing their interaction with each other. This involved creating a detailed list outlining how the tool would support this journey. Critical decisions regarding the tool and its journey were identified and highlighted to ensure alignment with project objectives and user needs.
RCT
The trial is expected to include its first patient in November 2025, we’re in the early process of the trial development
A theory-driven approach that aims to uncover the explanatory mechanisms that underpin interventions and how context affects the success or failure of intended outcomes.
The review protocol was developed and accepted on the PROSPERO Registry (CRD42022375000, 14 November 2022).
Four online stakeholder meetings were held across the 12 months of the review to ensure relevancy of the review questions and to identify any gaps as the data analysis progressed.
We summarised our findings under three themes:
1. The ‘prescribing inertia’ problem in end-of-life care
2. Shared decision-making in end-of-life deprescribing
3. Education, training and decision support for end-of-life shared decision-making
Manuscript is completed.
Flash mob research:
(UMCM) – 1 October 2022 to 1 October 2024
Study protocol version 1.0 of 23 January 2023 describing the procedures and timelines of this survey according to the flash mob approach was jointly prepared by UMCM and LUMC.
Data analysis and evaluation was jointly performed by UMCM and LUMC.
Manuscript is completed.
Epidemiological studies:
Contributing centers
Aalborg University Hospital: Danish Center for Health Services Research
Erasmus Medical Center: Department of Hematology
Leiden University Medical Center: Department of Internal Medicine, section Thrombosis and Hemostasis & Department of Clinical Epidemiology
Cardiff University: Division of Population Medicine
University Medical Center Utrecht: Julius Center for Health Sciences and Primary Care
Data analysis was standardized across the different settings and countries (definitions, CODE selection), and data has been analyzed and shared during several consortium meeting. Several manuscripts are anticipated this year, one manuscript is completed.
Qualitative studies:
The team in Denmark and Wales drafted the qualitative protocol, and supporting documents, including the participant information sheets (for patients, companions and clinicians), consent forms, and interview schedule/guide.
Interviews were conducted between April 2023 – March 2024. A total of 60 patients (13 companions) and 77 clinicians have been interviewed over this period (see Table 1 and 2). The minimum target recruitment has been reached (minimum 60 patients and 72 clinicians across all countries).
Data analysis
The data are being analysed using Framework Analysis; to date, analysis is well underway
Consensus/Delphi analysis
During the reporting period, the WP4 coordination group has been preparing the consensus process. To complete the documents and prepare the different meetings committee, members of the WP4 coordination group have been holding regular meetings. To establish the final framework of the Delphi, several steps were necessary, each playing a crucial role in the process: creation of a Steering Committee, consideration of aspects of the protocol, particularly defining the composition of the Delphi panel, and developing the Delphi content.
Design and development of the SDST
A comprehensive journey for both patients and clinicians was designed, emphasizing their interaction with each other. This involved creating a detailed list outlining how the tool would support this journey. Critical decisions regarding the tool and its journey were identified and highlighted to ensure alignment with project objectives and user needs.
RCT
The trial is expected to include its first patient in November 2025, we’re in the early process of the trial development
PPI Patient and Public Involvement – Cardiff University
We aim to include meaningful patient and public involvement across all work packages. With the range of methodologies used across all work packages, a strategic plan will be applied to enable collaborations between a team of PPIE experts, work-package leads and research teams. To enable this, we have established a Patient and Public Involvement and Engagement (PPIE) work package and PPIE team for SERENITY.
The main aims of the PPIE team are:
• to support the SERENITY study research teams to engage with patient and public contributors
• to help ensure that the research is appropriately conducted
• to help ensure the research is of high quality
• to optimise the impact of the research by ensuring that the development and implementation of the SDMST in local health services is suitable for the needs of local populations.
We aim to include meaningful patient and public involvement across all work packages. With the range of methodologies used across all work packages, a strategic plan will be applied to enable collaborations between a team of PPIE experts, work-package leads and research teams. To enable this, we have established a Patient and Public Involvement and Engagement (PPIE) work package and PPIE team for SERENITY.
The main aims of the PPIE team are:
• to support the SERENITY study research teams to engage with patient and public contributors
• to help ensure that the research is appropriately conducted
• to help ensure the research is of high quality
• to optimise the impact of the research by ensuring that the development and implementation of the SDMST in local health services is suitable for the needs of local populations.